# L_2012350EN.01008201.xml

| 20.12.2012 | EN | Official Journal of the European Union | L 350/82 |
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20.12.2012

EN

Official Journal of the European Union

L 350/82

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DECISION OF THE EUROPEAN PARLIAMENT

of 23 October 2012

on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010

(2012/802/EU)

THE EUROPEAN PARLIAMENT,

| — | having regard to the final annual accounts of the European Medicines Agency for the financial year 2010, |
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—

having regard to the final annual accounts of the European Medicines Agency for the financial year 2010,

| — | having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies (1), |
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—

having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies (1),

1

| — | having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012), |
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—

having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

| — | having regard to its Decision of 10 May 2012 (2) postponing the discharge decision in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the Agency, |
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—

having regard to its Decision of 10 May 2012 (2) postponing the discharge decision in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the Agency,

2

| — | having regard to Article 319 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 319 of the Treaty on the Functioning of the European Union,

| — | having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3), and in particular Article 185 thereof, |
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—

having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3), and in particular Article 185 thereof,

3

| — | having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency, and in particular Article 68 thereof, |
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—

having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency, and in particular Article 68 thereof,

4

| — | having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof, |
| --- | --- |

—

having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,

5

| — | having regard to the Joint Statement on decentralised agencies and the Common Approach annexed thereto, agreed in June 2012 by the European Parliament, the Council and the Commission, resulting from the work of the Inter-Institutional Working Group on decentralised agencies created in March 2009, and in particular the sections on governance, operation, programming, accountability and transparency of the Common Approach, |
| --- | --- |

—

having regard to the Joint Statement on decentralised agencies and the Common Approach annexed thereto, agreed in June 2012 by the European Parliament, the Council and the Commission, resulting from the work of the Inter-Institutional Working Group on decentralised agencies created in March 2009, and in particular the sections on governance, operation, programming, accountability and transparency of the Common Approach,

| — | having regard to Rule 77 of, and Annex VI to, its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

| — | having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012), |
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—

having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012),

| 1. | Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2010; |
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1.

Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2010;

| 2. | Sets out its observations in the resolution below; |
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2.

Sets out its observations in the resolution below;

| 3. | Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series). |
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3.

Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

Official Journal of the European Union

The President

Martin SCHULZ

The Secretary-General

Klaus WELLE

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(1)  OJ C 366, 15.12.2011, p. 27.

1

(2)  OJ L 286, 17.10.2012, p. 377.

2

(3)  OJ L 248, 16.9.2002, p. 1.

3

(4)  OJ L 136, 30.4.2004, p. 1.

4

(5)  OJ L 357, 31.12.2002, p. 72.

5

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RESOLUTION OF THE EUROPEAN PARLIAMENT

of 23 October 2012

with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010

THE EUROPEAN PARLIAMENT,

| — | having regard to the final annual accounts of the European Medicines Agency for the financial year 2010, |
| --- | --- |

—

having regard to the final annual accounts of the European Medicines Agency for the financial year 2010,

| — | having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies (1), |
| --- | --- |

—

having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies (1),

| — | having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012), |
| --- | --- |

—

having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

| — | having regard to its Decision of 10 May 2012 (2) postponing the discharge decision in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the Agency, |
| --- | --- |

—

having regard to its Decision of 10 May 2012 (2) postponing the discharge decision in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the Agency,

| — | having regard to Article 319 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 319 of the Treaty on the Functioning of the European Union,

| — | having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3), and in particular Article 185 thereof, |
| --- | --- |

—

having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3), and in particular Article 185 thereof,

| — | having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency, and in particular Article 68 thereof, |
| --- | --- |

—

having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency, and in particular Article 68 thereof,

| — | having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof, |
| --- | --- |

—

having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,

| — | having regard to the Joint Statement on decentralised agencies and the Common Approach annexed thereto, agreed in June 2012 by the European Parliament, the Council and the Commission, resulting from the work of the Inter-Institutional Working Group on decentralised agencies created in March 2009, and in particular the sections on governance, operation, programming, accountability and transparency of the Common Approach, |
| --- | --- |

—

having regard to the Joint Statement on decentralised agencies and the Common Approach annexed thereto, agreed in June 2012 by the European Parliament, the Council and the Commission, resulting from the work of the Inter-Institutional Working Group on decentralised agencies created in March 2009, and in particular the sections on governance, operation, programming, accountability and transparency of the Common Approach,

| — | having regard to Rule 77 of, and Annex VI to, its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

| — | having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012), |
| --- | --- |

—

having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012),

| A. | whereas on 10 May 2012, the European Parliament postponed its decision on the discharge and closure of the accounts of the European Medicines Agency (‘the Agency’) for the financial year 2010, |
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A.

whereas on 10 May 2012, the European Parliament postponed its decision on the discharge and closure of the accounts of the European Medicines Agency (‘the Agency’) for the financial year 2010,

| B. | whereas the Agency addressed to a large extent the weaknesses highlighted in the report of 10 May 2012 and provided the discharge authority with substantial information by letters of 2 and 6 July 2012 and of 2, 7 and 24 August 2012, |
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B.

whereas the Agency addressed to a large extent the weaknesses highlighted in the report of 10 May 2012 and provided the discharge authority with substantial information by letters of 2 and 6 July 2012 and of 2, 7 and 24 August 2012,

| C. | whereas the discharge is a valid instrument of the European Parliament, which requires a decision based on factual and substantive arguments; recalling, in this context, the existing rules, i.e. the Staff Regulations for Officials and Conditions of Employment of Other Servants of the European Community, the Financial Regulation applicable to the general budget of the European Communities, the Agency’s founding regulation and the specific policies and procedures set up by the Agency, |
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C.

whereas the discharge is a valid instrument of the European Parliament, which requires a decision based on factual and substantive arguments; recalling, in this context, the existing rules, i.e. the Staff Regulations for Officials and Conditions of Employment of Other Servants of the European Community, the Financial Regulation applicable to the general budget of the European Communities, the Agency’s founding regulation and the specific policies and procedures set up by the Agency,

| 1. | Recalls the importance of the work of the Agency by providing the best possible scientific advise on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human and veterinary use to the Member States and the institutions; |
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1.

Recalls the importance of the work of the Agency by providing the best possible scientific advise on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human and veterinary use to the Member States and the institutions;

Follow-up of 2009 discharge

| 2. | Notes that on 7 June 2012 the Management Board endorsed the new structure and scope of the Advisory Committee on Procurement and Contract; welcomes that the Agency put in place a multiannual procurement plan for 2012-2014 as requested by the discharge authority in its report on the discharge for the financial year 2009; |
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2.

Notes that on 7 June 2012 the Management Board endorsed the new structure and scope of the Advisory Committee on Procurement and Contract; welcomes that the Agency put in place a multiannual procurement plan for 2012-2014 as requested by the discharge authority in its report on the discharge for the financial year 2009;

Carryover appropriations and cancellations

| 3. | Reminds that the Court of Auditors reported a high level of carryovers for the financial year 2010 as well as a lack of compliance with the budgetary principle of annuality; welcomes the fact that the Agency has strengthened its procedures of fee revenue forecasting by creating a team which analyses, in close cooperation with the pharmaceutical industry, the status of pharmaceutical product research before submission to the Agency; notes the Agency’s firm commitment to work with Directorate-General Budget of the Commission in order to achieve a stable framework with the current revision of the Framework Financial Regulations; |
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3.

Reminds that the Court of Auditors reported a high level of carryovers for the financial year 2010 as well as a lack of compliance with the budgetary principle of annuality; welcomes the fact that the Agency has strengthened its procedures of fee revenue forecasting by creating a team which analyses, in close cooperation with the pharmaceutical industry, the status of pharmaceutical product research before submission to the Agency; notes the Agency’s firm commitment to work with Directorate-General Budget of the Commission in order to achieve a stable framework with the current revision of the Framework Financial Regulations;

| 4. | Gives full support to all efforts at the executive and administrative levels of the Agency to reform the payment system for services provided by Member States’ authorities which should clearly be based on the real costs; welcomes therefore the Agency’s initiative to prepare a new proposal to be submitted to the Management Board; urges and expects the Management Board to discuss and decide on this payment system without delay; |
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4.

Gives full support to all efforts at the executive and administrative levels of the Agency to reform the payment system for services provided by Member States’ authorities which should clearly be based on the real costs; welcomes therefore the Agency’s initiative to prepare a new proposal to be submitted to the Management Board; urges and expects the Management Board to discuss and decide on this payment system without delay;

Transparency and management of conflict of interest

| 5. | Takes note that the Agency is organising for November 2012 a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data, and that the selection and training of the Agency’s scientific staff aimed at strengthening the analysis of raw data is well advanced; |
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5.

Takes note that the Agency is organising for November 2012 a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data, and that the selection and training of the Agency’s scientific staff aimed at strengthening the analysis of raw data is well advanced;

| 6. | Takes note that the Agency has improved the scope and methodology of the systematic ex-ante and ex post controls related to the screening of declaration of interest; also welcomes the Agency’s decision to perform a yearly evaluation of its revised policy on declaration of interest; invites therefore the Agency to keep the discharge authority informed on the implementation of its revised policy, and in particular of its systematic ex ante and ex post controls, on a six month basis; |
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6.

Takes note that the Agency has improved the scope and methodology of the systematic ex-ante and ex post controls related to the screening of declaration of interest; also welcomes the Agency’s decision to perform a yearly evaluation of its revised policy on declaration of interest; invites therefore the Agency to keep the discharge authority informed on the implementation of its revised policy, and in particular of its systematic ex ante and ex post controls, on a six month basis;

| 7. | Notes with satisfaction that the Agency has started publishing the minutes of some scientific committees’ meetings, starting with the Paediatric Committee, in July 2012; takes note that the publication process of the minutes of all scientific committees’ meetings will be completed only by the end of 2013; |
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7.

Notes with satisfaction that the Agency has started publishing the minutes of some scientific committees’ meetings, starting with the Paediatric Committee, in July 2012; takes note that the publication process of the minutes of all scientific committees’ meetings will be completed only by the end of 2013;

| 8. | Notes that the concerns raised with regard to the financial circuits and the potential conflicts of interests in processing payments due to insufficient segregation of duties were addressed by the Agency with the introduction of SAP accounting software as its central financial system; |
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8.

Notes that the concerns raised with regard to the financial circuits and the potential conflicts of interests in processing payments due to insufficient segregation of duties were addressed by the Agency with the introduction of SAP accounting software as its central financial system;

| 9. | Underlines that in June 2012 a ‘revolving door’ case occurred in the Agency, as the former Head of the Legal Service joined as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients; takes note that the Executive Director of the Agency launched a review of the work performed by the former Head of the Legal Service; invites the Agency to inform the discharge authority on the outcomes of this review by the end of 2012; |
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9.

Underlines that in June 2012 a ‘revolving door’ case occurred in the Agency, as the former Head of the Legal Service joined as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients; takes note that the Executive Director of the Agency launched a review of the work performed by the former Head of the Legal Service; invites the Agency to inform the discharge authority on the outcomes of this review by the end of 2012;

| 10. | Takes note that the Agency proceeded to a screening process of the declarations of interest of its experts and committee members who have been actively involved in the Agency’s activities between 1 January and 31 May 2012 against their curriculum vitae; notes that around 54 % of the experts and committee members provided the Agency with updated curriculum vitae; calls on the Agency to inform the discharge authority on the timeframe and outcomes of the screening process for the remaining 46 % by the start of the next discharge procedure; |
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10.

Takes note that the Agency proceeded to a screening process of the declarations of interest of its experts and committee members who have been actively involved in the Agency’s activities between 1 January and 31 May 2012 against their curriculum vitae; notes that around 54 % of the experts and committee members provided the Agency with updated curriculum vitae; calls on the Agency to inform the discharge authority on the timeframe and outcomes of the screening process for the remaining 46 % by the start of the next discharge procedure;

| 11. | Welcomes the Agency’s initiative to publish on its website the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; welcomes the Agency’s commitment to publish next to the declarations of interest the professional and educational profiles of the scientific experts belonging to its Expert Database from the first quarter of 2013 and will follow closely the publication process during the future discharge procedures; |
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11.

Welcomes the Agency’s initiative to publish on its website the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; welcomes the Agency’s commitment to publish next to the declarations of interest the professional and educational profiles of the scientific experts belonging to its Expert Database from the first quarter of 2013 and will follow closely the publication process during the future discharge procedures;

| 12. | Welcomes the announcement by the Agency that it plans to introduce an ex ante and ex post system for declarations of interest, notably by means of random comparison with CVs and information provided by experts at national level; asks the Agency to provide the budgetary control authority with a precise timetable for the implementation of this new system; |
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12.

Welcomes the announcement by the Agency that it plans to introduce an ex ante and ex post system for declarations of interest, notably by means of random comparison with CVs and information provided by experts at national level; asks the Agency to provide the budgetary control authority with a precise timetable for the implementation of this new system;

| 13. | Agrees with the Agency that a high level of reliability and honesty concerning the declaration of interests can only be achieved if pharmaceutical companies themselves disclose the list of experts and research centres with which they work, and the sums concerned in their financial links with them; agrees with the Agency that thought should be given to whether a legislative initiative in this field would be pertinent; |
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13.

Agrees with the Agency that a high level of reliability and honesty concerning the declaration of interests can only be achieved if pharmaceutical companies themselves disclose the list of experts and research centres with which they work, and the sums concerned in their financial links with them; agrees with the Agency that thought should be given to whether a legislative initiative in this field would be pertinent;

| 14. | Acknowledges the Agency’s efforts to address the discharge authority’s concerns with regards to the prevention and management of conflict of interest; notes in particular the reports of 29 June 2012 and 7 August 2012 received by the discharge authority on the review of the conflict of interest management cases identified by the IAS and on the review of potential conflicts of interest of experts involved in assessing the medicinal product Pandemrix; |
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14.

Acknowledges the Agency’s efforts to address the discharge authority’s concerns with regards to the prevention and management of conflict of interest; notes in particular the reports of 29 June 2012 and 7 August 2012 received by the discharge authority on the review of the conflict of interest management cases identified by the IAS and on the review of potential conflicts of interest of experts involved in assessing the medicinal product Pandemrix;

| 15. | Is firmly convinced that necessary steps have to be taken should cases of non-compliance with existing rules occur; believes that, in such cases, the Agency should draw up an action plan, accompanied by a precise timetable, aiming to remedy the shortcomings, that its implementation should be monitored by the European Parliament, and that these problems should be addressed by changing the existing rules and regulations in order to eliminate possible loopholes; |
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15.

Is firmly convinced that necessary steps have to be taken should cases of non-compliance with existing rules occur; believes that, in such cases, the Agency should draw up an action plan, accompanied by a precise timetable, aiming to remedy the shortcomings, that its implementation should be monitored by the European Parliament, and that these problems should be addressed by changing the existing rules and regulations in order to eliminate possible loopholes;

| 16. | Calls on the Agency to introduce in its annual activity reports a special section describing the actions taken to prevent and manage conflict of interest, which should include, inter alia:






  — | the number of alleged cases of conflict of interest verified, |
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16.

Calls on the Agency to introduce in its annual activity reports a special section describing the actions taken to prevent and manage conflict of interest, which should include, inter alia:

—

the number of alleged cases of conflict of interest verified,

| — | the number of revolving door cases, |
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—

the number of revolving door cases,

| — | the measures taken in each category of cases, |
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—

the measures taken in each category of cases,

| — | the number of breach of trust procedures launched and their outcomes, |
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—

the number of breach of trust procedures launched and their outcomes,

| — | the penalties applied; |
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—

the penalties applied;

requests the Agency to inform the discharge authority of the detailed measures taken;

| 17. | Considers it noteworthy that the committee responsible is in close contact with the Agency by inviting the Executive Director for an exchange of views at least once a year, by having appointed a contact person from amongst its members and by visiting the Agency every two years; recalls that the last visit took place in June 2011; |
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17.

Considers it noteworthy that the committee responsible is in close contact with the Agency by inviting the Executive Director for an exchange of views at least once a year, by having appointed a contact person from amongst its members and by visiting the Agency every two years; recalls that the last visit took place in June 2011;

| 18. | Welcomes, in general, the Joint Statement and the Common Approach on decentralised agencies afore mentioned, which address and take up some elements important to the discharge procedure, and believes that the roadmap on the follow-up to the Common Approach, to be presented by the Commission by the end of 2012, will take due account of those issues; |
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18.

Welcomes, in general, the Joint Statement and the Common Approach on decentralised agencies afore mentioned, which address and take up some elements important to the discharge procedure, and believes that the roadmap on the follow-up to the Common Approach, to be presented by the Commission by the end of 2012, will take due account of those issues;

| 19. | Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2012 (6) on the performance, financial management and control of the agencies. |
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19.

Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2012 (6) on the performance, financial management and control of the agencies.

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(1)  OJ C 366, 15.12.2011, p. 27.

(2)  OJ L 286, 17.10.2012, p. 377.

(3)  OJ L 248, 16.9.2002, p. 1.

(4)  OJ L 136, 30.4.2004, p. 1.

(5)  OJ L 357, 31.12.2002, p. 72.

(6)  OJ L 286, 17.10.2012, p. 388.

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